Core B: THE IMMUNOLOGIC MONITORING AND DIAGNOSTIC LABORATORY (IMDL) will assume responsibility for providing immunologic laboratory support for the Cytokine Gene Therapy Program. The specific objectives of the IMDL will as follows: 1) to establish in culture, expand and transduce, with the IL4, IL10, or IL12, gene autologous human fibroblasts for vaccine preparation; 2) to select and evaluate gene expression for cytokines IL4, IL10, or IL12 in transduced fibroblasts, using quantitative RT-PCR; 3) to measure by immunoassays the ability of transduced and selected fibroblasts to produce these cytokines as well as other constitutive or induced fibroblast cytokines; 4) to perform safety testing on transduced fibroblasts; 5) to prepare vaccines using preserved autologous tumor cells and transduced fibroblasts; 6) to provide immunologic monitoring, including cytokine assays, for all projects of this program; 7) to procure, process and bank human tumor specimens for all projects; 8) to interact with investigators in Projects 1-3 in the development of genetically-modified effector or tumor cells for in vivo and in vitro preclinical studies as well as for clinical use. For all therapeutic cultures or products used clinically, the IMDL will perform evaluations of quality and sterility. To meet these diverse requirements, the core laboratory will be organized into: a) an adoptive immunotherapy (AIT) unit dedicated to preparation of human effector or other cell cultures for therapy, including transfection, selection and growth of genetically- modified cells; b) tissue bank; c) monitoring laboratory, and d) research laboratory in which quantitative RT-PCR will be performed. The core laboratory will operate according to the FDA guidelines for the preparation of biologic products for therapy.
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